A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas
- Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antiangiogenic activity of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent
enzyme-inducing antiepileptic drugs (yes vs no).
Patients receive oral CC-5013 weekly for 3 weeks. Treatment repeats every 4 weeks for up to
12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A maximum of 80 patients (40 per stratum) will be accrued for this study
within 20 months.
Primary Purpose: Treatment
Howard A. Fine, MD
NCI - Neuro-Oncology Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|